Aurora Software Version 1.3 Upgrade Kit 6R2013

GUDID 04086000101059

A software upgrade package (accessory) to the Aurora Plasmapheresis System (primary device). For collection of plasma by membrane filtration.

Fresenius Kabi AG

Apheresis system
Primary Device ID04086000101059
NIH Device Record Key0906c405-f689-4018-8b4b-80a31cb53a3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAurora Software Version 1.3 Upgrade Kit
Version Model Number6R2013
Catalog Number6R2013
Company DUNS315654579
Company NameFresenius Kabi AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000101059 [Primary]
GS114086000101056 [Package]
Package: Carton [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKTSeparator, Automated, Blood Cell, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

Devices Manufactured by Fresenius Kabi AG

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10810020441649 - Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual2024-02-01 For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. F
14086000101032 - ALYX 2RBC-LR Kit with Saline Spike2023-12-21 For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use with the ALYX System. Sterile fluid path.
00810020441192 - AMICUS Separator Life Extension Software2023-06-01 Software version for AMICUS Separator Life Extension Device

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